CONTRACT MANUFACTURING

The future of outsourcing

Contract Manufacturing Organizations

The contract manufacturing (CMO) industry is forecast to show strong growth, with total revenues rising by 13.0% per year, on average. In 2005, the market was worth $31.5bn but by 2010 will account for just under $50bn.

The growth of biologics is at the heart of CMO growth. Unlike pharma-derived NCEs, material used in Phase III studies for biopharmaceuticals must generally be produced using the final manufacturing process that will be employed in commercial production, including the site of manufacture. This requirement makes outsourced manufacturing even more attractive for biotech drugs than conventional pharmaceuticals, since drug developers risk major capital investment before an investigational compound has demonstrated safety and efficacy. Accordingly, In 2005 survey 40% of biotech scientists believed GMP manufacturing should be outsourced.

A second major driver of growth in CMO is in biosimilars, with many high selling biologic drugs reaching patent expiry in the next few years. In addition, the approval process for biosimilar drugs is making progress with regulations established in the EU and US soon to follow. With the regulations for bioequivalent drug approval imminent there is a need for more efficient and cheaper methods for manufacturing, which is also helping drive investment in CMOs.

Our new outsourcing portfolio of reports is designed to help decision makers:

• Plan resources and budgets effectively
• Understand the future role of CMOs in improving pharma productivity
• Optimizing performance of outsourced companies as part of the manufacturing process